Adventitious Agents Testing via NGS

Next generation sequencing (NGS) is quickly gaining regulatory agencies' acceptance as a sensitive and un-biased detection method for adventitious agents. Avance Biosciences is positioned to be a strategic partner with our pharmaceutical clients in establishing this powerful tool for testing viral contaminants in cell substrates and biological products.


Experiences

Working closely with a major US-based pharmaceutical client, Avance Biosciences developed its NGS viral detection work flow that is capable of detecting various viruses (dsDNA, ssDNA, ssRNA, and dsRNA viruses) at low concentrations. Avance Biosciences has since successfully completed two GMP-level viral detection projects for this client in support of their viral vaccine applications.

And more recently, Avance Biosciences has also participated in a collaborative study organized by National Institute for Biological Standards and Control (NIBSC) to compare the abilities of NGS methods to identify viruses in a reference material. Avance Biosciences’ data are consistent with the results of the majority of the participating labs and correlates well with the qPCR data released by NIBSC after NGS data submission.

Methodology

NGS-viral

Applications

  • Testing adventitious viruses in biological products
    • Raw materials
    • Final products
    • Matrix with viral spike-in
  • Testing adventitious viruses in cell substrates
    • Cell culture
    • Supernatant after cell precipitation

 

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